A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT04161976|
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: LY900027 Drug: Insulin Lispro||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy|
|Actual Study Start Date :||December 27, 2019|
|Estimated Primary Completion Date :||July 20, 2020|
|Estimated Study Completion Date :||July 20, 2020|
LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.
LY900027 administered to participants with T1DM using CSII.
Active Comparator: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.
Drug: Insulin Lispro
Insulin lispro administered to participants with T1DM using CSII.
- Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT) [ Time Frame: Day 1 through Day 10 in each dosing period ]PK: AUC after Bolus Administration Prior to a MMTT
- PK: Maximum Observed Insulin Lispro Concentration (Cmax) [ Time Frame: Day 1 through Day 10 in each dosing period ]PK: C PK: Cmax
- Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion [ Time Frame: Day 1 through Day 10 in each dosing period ]PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
- PD: Total Daily Insulin Dose [ Time Frame: Day 1 through Day 10 in each dosing period ]PD: Total Daily Insulin Dose
- Duration Until Catheter Failure [ Time Frame: Day -1 through Day 10 in each dosing period ]Duration Until Catheter Failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161976
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||ClinicalTrials.email@example.com|
|Profil Institut für Stoffwechselforschung||Recruiting|
|Neuss, Nordrhein-Westfalen, Germany, 41460|
|Principal Investigator: Oliver Klein|
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|